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WO2002034234A2 - Formulations a liberation modifiee par methylphenidate - Google Patents

Formulations a liberation modifiee par methylphenidate Download PDF

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Publication number
WO2002034234A2
WO2002034234A2 PCT/US2001/042561 US0142561W WO0234234A2 WO 2002034234 A2 WO2002034234 A2 WO 2002034234A2 US 0142561 W US0142561 W US 0142561W WO 0234234 A2 WO0234234 A2 WO 0234234A2
Authority
WO
WIPO (PCT)
Prior art keywords
beads
methylphenidate
delivery system
drug
drug delivery
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2001/042561
Other languages
English (en)
Other versions
WO2002034234A3 (fr
Inventor
Marie J. Bettman
Dan L. Hensley
Phillip J. Percel
Gopi M. Venkatesh
Krishna S. Vishnupad
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
UCB Manufacturing Inc
Adare Pharma Solutions Inc
Original Assignee
Eurand America Inc
Celltech Manufacturing CA Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24802604&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2002034234(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to CA2426883A priority Critical patent/CA2426883C/fr
Priority to AU2001297011A priority patent/AU2001297011B2/en
Priority to EP01977934A priority patent/EP1328251A2/fr
Priority to JP2002537288A priority patent/JP2004512296A/ja
Priority to AU9701101A priority patent/AU9701101A/xx
Application filed by Eurand America Inc, Celltech Manufacturing CA Inc filed Critical Eurand America Inc
Priority to HU0303695A priority patent/HUP0303695A3/hu
Priority to PL361673A priority patent/PL203828B1/pl
Publication of WO2002034234A2 publication Critical patent/WO2002034234A2/fr
Publication of WO2002034234A3 publication Critical patent/WO2002034234A3/fr
Priority to NO20031843A priority patent/NO20031843D0/no
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4458—Non condensed piperidines, e.g. piperocaine only substituted in position 2, e.g. methylphenidate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Definitions

  • Methylphenidate Hydrochloride a scheduled II controlled substance, is currently marketed as a mild central nervous system (CNS) stimulant and the drug of choice for treatment of ADD and ADHA in children.
  • the drug is well absorbed throughout the gastrointestinal tract. However, it has an extremely short half-life, which necessitates a multi-dose treatment regimen for conventional (immediate release) dosage forms such as currently available 5, 10, and 20 mg tablets. Due to high C max , oral administration of 10 and 20 mg Ritalin® is reported to result in notable side effects such as anorexia, weight loss, dizziness, etc. Furthermore, it requires the hyperactive children to be dosed in school thus causing hardship to school authorities as well as parents.
  • Methylphenidate also produces a euphoric effect when administered intravenously or through inhalation, thus presenting a high potential for substance abuse.
  • Sustained release formulations for once-a-day dosing such as 20 mg Ritalin SR® tablets currently available from Novartis and Geneva (generic version), were developed with the objective of providing efficacy for 8 hours, thereby improving compliance and reducing the incidence of diversion.
  • the sustained release formulations exhibit a slower onset of action/efficacy compared to the immediate release dosage forms (W.E. Pelham et al., "Sustained Release And Standard Methylphenidate Effects On Cognitive And Social Behavior In Children With Attention Deficit Disorder," Pediatrics, Vol. 80, pp 491-501 (1987).
  • Fig. 1 is a graph showing the mean plasma concentration profile for various dosage forms described in example 2;
  • Fig. 3 is a graphical representation of the stability data for modified release methylphenidate hydrochloride capsules, 20 mg (30 IR/70 ER Beads) at 30° C/60% RH; and
  • Fig. 4 is a graphical representation of the stability data for modified release methylphenidate hydrochloride capsules, 20 mg (30 IR/70 ER Beads) at 40°C/75% RH. DETAILED DESCRIPTION OF THE INVENTION
  • ER Beads are produced by coating IR Beads with a solution or an aqueous dispersion of a dissolution rate controlling polymer thereby forming an extended release membrane coating on the IR bead.
  • dissolution rate controlling polymers include, but are not limited to, ethylcellulose (e.g., Aquacoat® ECD-30), neutral copolymers based on ethylacrylate and methylmethacrylate, and copolymers of acrylic and methacrylic acid esters having quaternary ammonium groups.
  • the membrane coated beads are also typically seal coated with HPMC to produce Extended Release (ER) Beads.
  • a plasticized ethylcellulose coating was applied to the methylphenidate particles (893 g) by spraying Aquacoat® ECD-30(233 g) and dibutyl sebacate (16.8 g).
  • An outer seal coating formulation (20 g) of Opadry was sprayed onto the coated active particles. The coated particles were cured at 60°C for 12 hours so that polymer particles coalesce to form a smooth membrane on ER Beads.
  • Methylphenidate HCl (1,168.4 g) was slowly added to a solution of polyvinylpyrrolidone (58.4 g Providone K-30) in 7,536 g of purified water and mixed well. 25-30 mesh sugar spheres (4,500 g) were coated with the drug solution in a Glatt fluid bed granulator GPCG 5. The drug containing pellets were dried, and a sealcoat of Opadry Clear (121.7 g) in 1,400 g purified water was first applied.
  • polyvinylpyrrolidone 58.4 g Providone K-30
  • 25-30 mesh sugar spheres (4,500 g) were coated with the drug solution in a Glatt fluid bed granulator GPCG 5.
  • the drug containing pellets were dried, and a sealcoat of Opadry Clear (121.7 g) in 1,400 g purified water was first applied.

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention porte sur une forme galénique pharmaceutique à multiparticules à libération modifiée telle qu'une capsule (une capsule à libération modifiée par jour) de méthylphénidate prescrite à des enfants présentant une hyperactivité avec déficit de l'attention. Cette formulation permet de délivrer une partie de la dose lors de l'apparition rapide de cette hyperactivité, le reste de la dose étant administré de manière régulée sur 12 heures. Cette formulation comprend une multitude de particules multicouches formant deux populations de billes enrobées d'un médicament, billes à libération immédiate et billes à libération prolongée. Le procédé de fabrication des billes à libération immédiate consiste à appliquer une couche d'une solution aqueuse comprenant un médicament et un liant sur des billes de sucre différentes et à appliquer ensuite une couche de protection sur les coeurs enrobés d'un médicament. Le procédé de fabrication des billes à libération prolongée consiste à appliquer sur des billes à libération immédiate un enrobage à libération prolongée d'un polymère insoluble dans l'eau régulant la vitesse de dissolution tel qu'une éthylcellulose. On fabrique les capsules à libération modifiée en remplissant les billes à libération immédiate et à libération prolongée dans un rapport correct ; la dose et le rapport nécessaires pour parvenir à un traitement efficace, de faible coût et adapté au patient sont déterminés à partir de longues recherches cliniques et d'établissement de corrélations in vitro/in vivo selon les principes directeurs FDA, les directives de l'Industrie : formes galéniques orales à libération prolongée.
PCT/US2001/042561 2000-10-27 2001-10-09 Formulations a liberation modifiee par methylphenidate Ceased WO2002034234A2 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
PL361673A PL203828B1 (pl) 2000-10-27 2001-10-09 Układ dostarczania leku chlorowodorku metylofenidatu z kapsułek o zmodyfikowanym uwalnianiu oraz sposób wytwarzania układu
AU2001297011A AU2001297011B2 (en) 2000-10-27 2001-10-09 Methylphenidate modified release formulations
EP01977934A EP1328251A2 (fr) 2000-10-27 2001-10-09 Formulations a liberation modifiee par methylphenidate
JP2002537288A JP2004512296A (ja) 2000-10-27 2001-10-09 メチルフェニデート改変放出製剤
AU9701101A AU9701101A (en) 2000-10-27 2001-10-09 Methylphenidate modified release formulations
CA2426883A CA2426883C (fr) 2000-10-27 2001-10-09 Formulations a liberation modifiee par methylphenidate
HU0303695A HUP0303695A3 (en) 2000-10-27 2001-10-09 Methylphenidate modified release formulations and process for their preparation
NO20031843A NO20031843D0 (no) 2000-10-27 2003-04-24 Metylfenidatmodifiserte frigjöringspreparater

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/697,803 2000-10-27
US09/697,803 US6344215B1 (en) 2000-10-27 2000-10-27 Methylphenidate modified release formulations

Publications (2)

Publication Number Publication Date
WO2002034234A2 true WO2002034234A2 (fr) 2002-05-02
WO2002034234A3 WO2002034234A3 (fr) 2002-12-05

Family

ID=24802604

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/042561 Ceased WO2002034234A2 (fr) 2000-10-27 2001-10-09 Formulations a liberation modifiee par methylphenidate

Country Status (13)

Country Link
US (1) US6344215B1 (fr)
EP (4) EP2269605A3 (fr)
JP (1) JP2004512296A (fr)
AU (2) AU9701101A (fr)
CA (1) CA2426883C (fr)
CY (1) CY1118946T1 (fr)
DK (1) DK2103307T3 (fr)
ES (1) ES2618603T3 (fr)
HU (1) HUP0303695A3 (fr)
NO (1) NO20031843D0 (fr)
PL (1) PL203828B1 (fr)
PT (1) PT2103307T (fr)
WO (1) WO2002034234A2 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
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WO2006015485A1 (fr) * 2004-08-12 2006-02-16 Bernard Charles Sherman Gelules a liberation prolongee comprenant du venlafaxine chlorhydrate
EP2269605A2 (fr) 2000-10-27 2011-01-05 Shire Pharmaceuticals Ireland Limited Formulations de libération modifiée de méthylphénidate
US11103494B2 (en) 2012-08-15 2021-08-31 Tris Pharma, Inc Methylphenidate extended release chewable tablet
US11590081B1 (en) 2017-09-24 2023-02-28 Tris Pharma, Inc Extended release amphetamine tablets
US11590228B1 (en) 2015-09-08 2023-02-28 Tris Pharma, Inc Extended release amphetamine compositions
US12458592B1 (en) 2017-09-24 2025-11-04 Tris Pharma, Inc. Extended release amphetamine tablets

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HUP0303695A3 (en) 2010-03-29
EP2103307B1 (fr) 2016-12-07
EP2286815A2 (fr) 2011-02-23
EP1328251A2 (fr) 2003-07-23
CY1118946T1 (el) 2018-01-10
PL361673A1 (en) 2004-10-04
NO20031843L (no) 2003-04-24
EP2269605A2 (fr) 2011-01-05
AU9701101A (en) 2002-05-06
AU2001297011B2 (en) 2007-03-15
PL203828B1 (pl) 2009-11-30
CA2426883A1 (fr) 2002-05-02
DK2103307T3 (en) 2017-03-13
NO20031843D0 (no) 2003-04-24
WO2002034234A3 (fr) 2002-12-05
EP2286815A3 (fr) 2011-06-29
JP2004512296A (ja) 2004-04-22
EP2103307A2 (fr) 2009-09-23
PT2103307T (pt) 2017-03-14
US6344215B1 (en) 2002-02-05
EP2103307A3 (fr) 2010-04-28
HUP0303695A2 (hu) 2004-03-01
EP2103307B9 (fr) 2017-03-01
EP2269605A3 (fr) 2011-06-29
ES2618603T3 (es) 2017-06-21
CA2426883C (fr) 2010-08-24

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